User Manual

Central Drugs Standard Control Organization

(CDSCO)

User Manual

For

SAE reporting (Serious Adverse Event)

On SUGAM portal

Version 1.0

Centre for Development of Advanced Computing

(A Scientific Society of the Ministry of Electronics and Information Technology, Govt. of India)
Anusandhan Bhawan, C-56/1, Institutional Area, Sector-62, Noida-201307
Phone: 91-120-3063311-14 Website:http://www.cdac.in

This is a controlled document. Unauthorized access, copying and replication are prohibited. This document must not be copied
in whole or part by any means, without the written authorization of CDAC, Noida

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TABLE OF CONTENTS

Serious Adverse Events ....................................................................................................................... 3

1.1 What is a Serious Adverse Event ........................................................................................................ 4
1.2 General SAE Reporting Policy .............................................................................................................. 5
1.2.1 Timeframe for initial SAE reports submission ...................................................................... 5
1.2.2 Recipients of SAEs reports ............................................................................................................ 5
1.3 Process Flow for SAEs Reporting........................................................................................................ 7
SAE Reporting ....................................................................................................................................... 15
2.1 SAE Reporting (24 Hours) .................................................................................................................. 17
2.2 SAE Reporting (14th Day due Analysis Report) .......................................................................... 19
2.3 SAE Reporting (14th Day Report by Sponsor) ............................................................................. 31
2.4 SAE Reporting (30th Day Report)..................................................................................................... 33
SAE Reporting For Offline CT (Applicable for CT-NOC’s issued offline and not through
SUGAM online application system) ............................................................................................... 39
3.1 SAE Reporting (24 Hours) .................................................................................................................. 42
3.2 SAE Reporting (14th Day due Analysis Report) .......................................................................... 45
3.3 SAE Reporting (14th Day Report by Sponsor) ............................................................................. 47
3.4 SAE Reporting (30th Day Report)..................................................................................................... 49
E-Vartalaap ............................................................................................................................................ 53
Important Notes................................................................................................................................... 56

LIST OF FIGURES .................................................................................................................................. 57

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Chapter-1
Serious Adverse Events

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1.1 What is a Serious Adverse Event

A Serious Adverse Event (SAE) is defined as any adverse drug event (experience) occurring at
any dose that in the opinion of either the investigator or sponsor results in any of the following
outcomes:
1) Death
2) Life-threatening adverse drug experience
3) Inpatient hospitalization or prolongation of existing hospitalization (for >24 hours)
4) Persistent or significant incapacity or substantial disruption of the abilityto
conductnormal life functions
5) Congenital anomaly/birth defect
6) Important Medical Event (IME) that may not result in death, be life threatening,
orrequire hospitalization may be considered a serious adverse drug experience
when,based upon medicaljudgment, it may jeopardize the patient or subject and
mayrequire medical or surgical intervention to prevent one of the outcomes listed in
thisdefinition.

It is important to remember that all SAEs are adverse events, but not all adverse events are SAEs

A “Life Threatening Adverse Drug Experience” defined as

Any adverse experience that places the subject, in the view of the investigator, at immediate
risk of death from the reaction as it occurred, or it is suspected that the use or continued use of
the product would result in the patient’s death.

“Congenital Anomaly” defined as

Exposure to a medical product prior to conception or during pregnancy resulting in an adverse
outcome in the child.

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1.2 General SAE Reporting Policy

A Serious Adverse Event report must be submitted on any event which meets the reporting
1.1criteria occurred during conduct of a clinical trial in India.

1.2.1 Timeframe for initial SAE reports submission

The investigator shall report all serious adverse events to the Central LicensingAuthority
(CDSCO), the sponsor or its representative and the Ethics Committee within twenty-four hours
of their occurrence and after due analysis to the Central Licensing Authority, Ethics Committee
and the head of the institution within fourteen days of the knowledge of occurrence of serious
adverse event.

The sponsor or its representative shall report all serious adverse events to the Central Licensing
Authority (CDSCO), head of the institution andEthics Committee within fourteen days of the
knowledge of occurrence of serious adverse event.

The Ethics Committee shall forward its report on serious adverse event within a period of thirty
days of receiving the report of the serious adverse event from the investigator.

1.2.2 Recipients of SAEs reports

Site Principal Investigators (PI), who confirmed that SAEs occurred in their trial, are required to
report the SAEs to CDSCO and also to their Trial Sponsor and Ethics Committees.

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Figure 1: CT SAE Reporting/Monitoring

Figure1 above depicts the Mapping of PI with Site.

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1.3 Process Flow for SAEs Reporting

After obtaining CT-NOC from CDSCO and registering at Clinical Trials Registry-India (CTRI), the
sponsor may initiatetrial and shall monitor the clinical trial in all the participating sites. To
report SAE on SUGAM portal, sponsor shall mandatorily follow the below mentioned steps to
build-up the database and for proper linking of data.
• Add Site Investigator
• Site Investigator Mapping
• Initiate Clinical Trial
• SAE Reported
To accomplish above steps, the Sponsor may login into the SUGAMportal and then click on
CLINICAL TRIALS tab under MENU from their dashboard.

Step 1: Add Site Principal Investigator

As the Sponsor/Applicant, when receives CT NOC, it only contains details of trial sites (i.e.
Hospital), Ethics committee and PI name (but not PI details and each PI has to register
themselves in the portal to report SAE).

After login into the portal, click on “Add Site Investigator” tab under “Clinical Trials” in Menu as
shown in below figure.

Figure 2: Sponsor Dashboard

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After that a new window will open as shown in below figure. Sponsor has to enter the
Investigator’s basic details and click on “Submit” button. He must add all the investigators
mentioned in the CT-NOC.

Figure 3: Site Investigator Registration

On clicking Submit button, an e-mail link will be sent to Investigator for confirming and creating
his login credentials. Once the investigator clicks the e-mail link, a window will open as shown
in figurebelow:

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Figure 4: Login Credential Window

The User Id is auto fetched (i.e. same as entered by applicant/sponsor), investigator needs to
enter only Password and Confirm Password. After clicking on “Save” button a message will pop-
up as shown in figurebelow:

Figure 5: Successful Registration Pop-up

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Once the login credentials of Investigators are created meanwhile, they must login into the
SUGAM portal to complete their user profile.

Step 2: Site Investigator Mapping

After the registration of Investigator’s User Profile, Applicant/Sponsor will map them with the
trial Site/Hospital from his dashboard.

Click on “Site Investigator Mapping” tab under “Clinical Trials” in Menu as shown in figure
below:

Figure 6: Sponsor Dashboard

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After that a new window will open as shown in figurebelow. Applicant/Sponsor has to select
the BE/CT application, a list of sites mentioned in the CT-NOC will get displayed. Just select the
site investigator from drop down and check the checkbox (as highlighted) and click on “Save”
button.

Figure 7: Application Investigator Mapping Form

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Step 3: Initiate Clinical Trial

Once the Site Investigator mapping is done for any BE/CT application, the applicant/sponsor
can initiate the trial.

Click on “Initiate CT” tab under “Clinical Trials” in Menu as shown in figure below:

Figure 8: Sponsor Dashboard

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After that, a new window will open as shown in figurebelow. Applicant/Sponsor has to select
the BE/CT application and enter the CTRI Registration Number, then click on “Save” button.

Figure 9: Initiate Clinical Trial Window

Step 4: SAE Reported

After the initiation of the clinical trial SAE occurring at any trial site has to be reported by
investigator, sponsor and ethics committee involved in that particular clinical trial.

An applicant/sponsor can view the list of all reported SAEs, for that, just Click on “SAE
Reported” tab under “Clinical Trials” in Menu as shown in figure below:

Figure 10: Sponsor Dashboard

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After that a new window will open as shown in figure below. Applicant/Sponsor can view or
report SAEs by clicking on options available under ‘Action’ button (as highlighted).

Figure 11: List of SAEs reported by Site Investigator

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Chapter- 2

SAE Reporting

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To report serious adverse events (SAE), there are three types of forms:
• SAE Reporting (24-hour Report by PI)
• SAE Reporting (14th Day Due Analysis Report by PI and Sponsor)
• SAE Reporting (30th Day Report by Ethics Committee)

While SAE reporting all the data (Sponsor/CRO details, Ethics committee details, Hospital/Site
details, PI details) will be fetched automatically based on BE/CT NOC number and rest details
will be entered depending on the form.

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2.1 SAE Reporting (24 Hours)

Investigator will fill the SAE Reporting form with the following details:

➢ Administrative Information
• SAE report of death or non-death (to be filled)
• Sponsor/CRO details (Auto fetch from CT NOC)
• Clinical Site details (Auto fetch from CT NOC)
• Investigator details (from PI registration)
• Ethics Committee details (Auto fetch from CT NOC)
➢ Clinical Study/BE Study details
• Study title & Protocol No. (Auto fetch from CT NOC)
➢ Patient/Subject details
• Unique Identifier (Initials/Subject No.)
• Gender
• Date of birth and age at the time of SAE
• Height & Weight
➢ SAE(s) Details
• SAE(s) Term(to be filled)
• Start date of SAE(to be filled)
• Stop date of SAE/ongoing
• Table-5(Upload)

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Figure 12: SAE Reporting Form24 hours

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After final submission of 24Hrs SAE reporting, a unique file number will be generated for future
reference as shown inFigure.

Figure 13: File Number for 24Hour Reporting

2.2 SAE Reporting (14th Day due Analysis Report)

After 24-hour SAE report is submitted, investigator may proceed to fill the Due Analysis
Report. This form is divided into several parts. A report may be submitted only after all the
parts of the form are completed. Before clicking the SUBMIT button Investigator may verify the
filled data from preview page.

Investigator shall fill the SAE Reporting form with the following details:
➢ Administrative Information
• SAE report of death or other than death(to be filled)
• Type of Report (to be filled)
• Sponsor/CRO details (Auto fetch from CT NOC)
• Clinical Site details(Auto fetch from CT NOC)
• Investigator’s details (Auto fetch from PI registration)
• Ethics Committee details(Auto fetch from CT NOC)
➢ Clinical Study/BE Study details
• Study title & Protocol No.(Auto fetch from CT NOC)
➢ Patient/Subject details
• Unique Identifier (Initials/Subject No)(Auto fetch from 24-hour report)
• Gender (Auto fetch from 24-hour report)
• Date of birth and age at the time of SAE(Auto fetch from 24-hour report)
• Weight & Height(Auto fetch from 24-hour report)
• Previous disease/medical history(to be filled)
➢ SAE(s) Details
• SAE(s) Term (Auto fetch from 24-hour report)
• SAE Management Setting (to be filled)
• Start date of SAE (Auto fetch from 24-hour report)
• Stop date of SAE (Auto fetch from 24-hour report)

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• Re challenge/De challenge Details (to be filled)

➢ Investigational/Suspected drug(s)/Device Details (to be filled)
➢ Any concomitant Drug(s) taken by the subject/patient.(Exclude those used for treating
SAE) (to be filled)
➢ SAE Management (to be filled)
➢ Baseline Lab Investigation Details (At the time of screening) (to be filled)
➢ Details of Lab Investigation done (On and before Onset of SAE) (to be filled)
➢ SAE case narrative and Due analysis/Causality of the SAE (to be filled)

As figures below:

Figure 14: 14 days Due Analysis Report Form List

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Figure 15: 14th day Due Analysis Report (Administrative Information)

Figure 16: 14th day Due Analysis Report (Patient/Subject Details)

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Figure 17: 14th day Due Analysis Report (SAE Details)

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Figure 18: 14th day Due Analysis Report (Investigational/Suspected drugs/Device details)

Figure 19: 14th day Due Analysis Report (Concomitant Drug Details)

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Figure 20: 14th day Due Analysis Report (SAE Management)

Figure 21: 14th day Due Analysis Report (Baseline Lab Investigation Details)

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Figure 22: 14th day Due Analysis Report (Lab Investigation done during clinical trial)

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Figure 23: 14th day Due Analysis Report (Due Analysis/Causality of the SAE (Part 1))

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Figure 24: 14th day Due Analysis Report (Due Analysis/Causality of the SAE (Part 2))

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Figure 25: 14th day Due Analysis Report (Upload Document)

Figure 26: 14th day Due Analysis Report (Intervention Drug Detail)

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Figure 27: 14th day Due Analysis Report (Comparator Drug Detail)

After filling all forms of 14Day due Analysis Report, PI have to submit it by clicking on “SAE
Reporting 14Day form Preview” link as shown in Figure below:

Figure 28: Filled Form List of 14D Report by PI

After final submission of 14th Day SAE report, a unique file number is generated for future
reference as shown in Figure below:

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Figure 29: File number for 14Day report by PI

Figure 30: List of SAEs reported by Site Investigator

2.3 SAE Reporting (14th Day Report by Sponsor)

After 14-day report submitted by Investigator, the file will be displayed on Sponsor’s dashboard
as shown in Figure below:

Figure 31: List of SAEs reported by Site Investigator at Sponsor

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After clicking on “SAE Reporting 14th Day Form Preview” link, Sponsor can see the preview
details entered by PIand have to enter their remarks and submit 14 days report as shown in
figure below:

Figure 32: List of SAEs forms by Sponsor

Figure 33: SAE 14 days Due Analysis Report Form by Sponsor

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After final submission of 14th Day SAE report by Sponsor, a unique file number will be generated
for future reference as shown in Figure below:

Figure 34: File number for 14D report by Sponsor

After submitting 14 days report by sponsor,the status of this file will be changed on Sponsor’s
dashboard andthis file will be visible to Ethicscommittee to submit its 30 Day report as shown in
Figure.

Figure 35: List of SAEs reported by Sponsor at EC

2.4 SAE Reporting (30th Day Report)

After 14th day SAE report is submitted by investigator and sponsor, the ethics committee may
proceed to fill its 30th day SAE Report.

Step 1 - First map ethics committee form shown as figure: -

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Figure 36: Ethics Committee Mapping Form

Step 2 - After mapping the form, EC go to SAE Reported option as shown figurebelow:

Figure 37: SAE Reported option in the dashboard

Step 3 - EC can see the preview of submitted 24th and 14th day reports and fill the 30th days
form: -

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Figure 38: List of SAEs reported by Site Investigator at EC

Step 4 –30days form will open in new window and it looks as below: -

Figure 39: SAE Reporting (Part 1)

EC have to fill following details: -

1. SAE(s) details
2. Upload Minutes of Meetings.
3. Chairman Details
4. Due analysis report

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Figure 40: SAE Reporting (Part 2)

Once EC has filled all required details, there is an option to“save as draft” for future
modification and status will change as shown in figurebelow:

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Figure 41: List of SAEs reported by EC

After saving the form, EC will have option to modify the form

Figure 42: Options to modify the form

After final submission of 30th Day SAE report by EC, a unique file number will be generated for
future reference as shown in Figure below:

Figure 43: File number for 30th Day report by EC

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After successful submission, status will change as shown in Figure below:

Figure 44: Successful form submission

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Chapter- 3

SAE Reporting For Offline CT

(Applicable for CT-NOC’s issued offline and not
through SUGAM online application system)

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To Report SAE Firstly Sponsor has to map the offline CT Application with Investigator

Click on “Offline CT Investigator Mapping” tab under “Clinical Trials” in Menu as shown in figure
below:

Figure 445: Sponsor Dashboard

After clicking on the “Offline CT Investigator Mapping” tab , mapping page will be shown to
map the offline CT with Investigator as shown in figure below:

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Figure 46: Offline CT Investigator Mapping Page

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To report serious adverse events (SAE) for Offline CT , there are three types of forms same as
SAE reporting for online CT:
• SAE Reporting (24-hour Report by PI)
• SAE Reporting (14th Day Due Analysis Report by PI and Sponsor)
• SAE Reporting (30th Day Report by Ethics Committee)

Investigator has to click on “Report Offline CT SAE” to report SAE for offline CT.

Figure 47: Investigator Dashboard

3.1 SAE Reporting (24 Hours)

Investigator will fill the SAE Reporting form with the following details:

➢ BE/CT Application Number

➢ SAE Report Type
➢ Site No
➢ Protocol No
➢ Investigator Name
➢ Subject No

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Figure 48: SAE Reporting Form

Investigator can see the preview of the form after save as shown in below figure:

Figure 49: SAE Reporting Preview

Investigator has to fill Checklist For 24H reporting after clicking on “Proceed To Checklist”
shown in below figure:

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Figure 50: Checklist page for 24H SAE Reporting

Figure 51: Checklist page for 24H SAE Reporting

After filling all the checklist items investigator has to click on “Submit” button for the final
submission of the SAE Reporting .

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After final submission of 24H SAE report by Investigator, a unique file number will be
generated for future reference as shown in Figure below:

Figure 52: Successful form submission

After 24H SAE reporting , the 24H application is shown on Sponsor as well as to EC to fill 14D
SAE reporting and 30D SAE Reporting respectively.

3.2 SAE Reporting (14th Day due Analysis Report)

After 24-hour SAE report is submitted, investigator may proceed to fill the 14Day Due Analysis
Report.

Figure 53: SAE Reporting List

After clicking on “14th Day Due Analysis reporting” action, Investigator can see the preview of
the form.

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Figure 54: SAE Reporting Form Preview

Investigator has to fill Checklist For 14th Day reporting after clicking on “Proceed To Checklist”
shown in below figure:

Figure 55: Checklist page for 14D SAE reporting

After filling all the checklist items investigator has to click on “Submit” button for the final
submission of the SAE Reporting .
After final submission of 14th Day SAE report by Investigator, a unique file number will be
generated for future reference as shown in Figure below:

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Figure 56: Successful form submission

3.3 SAE Reporting (14th Day Report by Sponsor)

After 14-day report submitted by Investigator, the file will be displayed on Sponsor’s dashboard
as shown in Figure below:

Figure 57: Sponsor Dashboard

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Figure 58: SAE Reporting List

After clicking on “14th Day Due Analysis reporting” action, Investigator can see the preview of
the form.

Figure 59: SAE Reporting Preview

Sponsor has to fill Checklist For 14th Day reporting after clicking on “Proceed To Checklist”
shown in below figure:

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Figure 60: Checklist Page for 14D SAE Reporting by Sponsor

After filling all the checklist items Sponsor has to click on “Submit” button for the final
submission of the SAE Reporting .
After final submission of 14th Day SAE report by Sponsor, a unique file number will be
generated for future reference as shown in Figure below:

Figure 61: Successful form submission

3.4 SAE Reporting (30th Day Report)

After 14th day SAE report is submitted by investigator and sponsor, the ethics committee may
proceed to fill its 30th day SAE Report.

Step 1 - First map ethics committee form shown as figure: -

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Figure 62: EC Dashboard

Step 2 - After mapping the form, EC go to SAE Reported option as shown figure below:

Figure 63: Offline CT Investigator Mapping

Step 3 - EC can see the preview of submitted 24th and 14th day reports and fill the 30th days
form: -

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Figure 64: SAE Reporting List

Step 4 –30days form will open in new window and it looks as below: -

Figure 646: SAE Reporting Preview

EC has to fill Checklist For 30th Day reporting after clicking on “Proceed To Checklist” shown in
below figure:

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Figure 66: Checklist Page for 30D SAE Reporting by EC

After filling all the checklist items EC has to click on “Submit” button for the final submission of
the SAE Reporting .
After final submission of 30th Day SAE report by Sponsor, a unique file number will be
generated for future reference as shown in Figure below:

Figure 67: Successful form submission

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Chapter- 4

E-Vartalaap

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To communicate with official, Applicant can use e-vartalaap facility.

Step 1: Click on chat icon which is just after the file number as shown in figure below:

Figure 68: Chat icon in SAE Reporting List

After clicking on chat icon, a communication box has open for entering the remarks. Applicant
can enter their remarks and uploaded the supported document(if any) as shown in below:

Figure 69: Communication Model

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After sending the message to the official, Applicant can view their previous communication on
clicking on same chat icon as shown in figure below.

Figure 70: Previous Communication view

If Applicant can again communicate with official after clicking on the “Write to Officials” button
as shown below:

Figure 71: Communication Model with previous chat

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Important Notes
1. All the follow up reports are to be submitted via e-vartalaap.
2. Applicant may report SAE through Offline SAE reporting process under the " Clinical
Trail" menu for the additional site for which approval received in Hard copy or are not
available on SUGAM Portal.
3. Sponsor can view mapped sites with investigators on clicking the tab “View mapped
sites & PI” tab under the site PI mapping page. If the mapping of site and investigator is
done by the sponsor then it will be automatically reflected at Investigator’s dashboard.

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LIST OF FIGURES
Figure 1: CT SAE Reporting/Monitoring...................................................................................................... 6
Figure 2: Sponsor Dashboard ........................................................................................................................... 7
Figure 3: Site Investigator Registration ....................................................................................................... 8
Figure 4: Login Credential Window ............................................................................................................... 9
Figure 5: Successful Registration Pop-up .................................................................................................... 9
Figure 6: Sponsor Dashboard ........................................................................................................................ 10
Figure 7: Application Investigator Mapping Form ................................................................................ 11
Figure 8: Sponsor Dashboard ........................................................................................................................ 12
Figure 9: Initiate Clinical Trial Window .................................................................................................... 13
Figure 10: Sponsor Dashboard ..................................................................................................................... 13
Figure 11: List of SAEs reported by Site Investigator .......................................................................... 14
Figure 12: SAE Reporting Form24 hours.................................................................................................. 18
Figure 13: File Number for 24Hour Reporting ....................................................................................... 19
Figure 14: 14 days Due Analysis Report Form List .............................................................................. 20
Figure 15: 14th day Due Analysis Report (Administrative Information) .................................... 22
Figure 16: 14th day Due Analysis Report (Patient/Subject Details) ............................................. 22
Figure 17: 14th day Due Analysis Report ( SAE Details) .................................................................... 23
Figure 18: 14th day Due Analysis Report (Investigational/Suspected drugs/Device details)
................................................................................................................................................................................... 24
Figure 19: 14th day Due Analysis Report (Concomitant Drug Details) ........................................ 24
Figure 20: 14th day Due Analysis Report ( SAE Management)........................................................ 25
Figure 21: 14th day Due Analysis Report (Baseline Lab Investigation Details)........................ 25
Figure 22: 14th day Due Analysis Report (Lab Investigation done during clinical trial) ...... 26
Figure 23: 14th day Due Analysis Report (Due Analysis/Causality of the SAE (Part 1)) ...... 27
Figure 24: 14th day Due Analysis Report (Due Analysis/Causality of the SAE (Part 2)) ...... 28
Figure 25: 14th day Due Analysis Report (Upload Document) ........................................................ 29
Figure 26: 14th day Due Analysis Report (Intervention Drug Detail) .......................................... 29
Figure 27: 14th day Due Analysis Report (Comparator Drug Detail) .......................................... 30
Figure 28: Filled Form List of 14D Report by PI .................................................................................... 30
Figure 29: File number for 14Day report by PI ...................................................................................... 31
Figure 30: List of SAEs reported by Site Investigator .......................................................................... 31
Figure 31: List of SAEs reported by Site Investigator at Sponsor ................................................... 31
Figure 32: List of SAEs forms by Sponsor................................................................................................. 32
Figure 33: SAE 14 days Due Analysis Report Form by Sponsor ...................................................... 32
Figure 34: File number for 14D report by Sponsor .............................................................................. 32
Figure 35: List of SAEs reported by Sponsor at EC ............................................................................... 33
Figure 36: Ethics Committee Mapping Form .......................................................................................... 34
Figure 37: SAE Reported option in the dashboard ............................................................................... 34
Figure 38: List of SAEs reported by Site Investigator at EC .............................................................. 35
Figure 39: SAE Reporting (Part 1) ............................................................................................................... 35
Figure 40: SAE Reporting (Part 2) ............................................................................................................... 36
Figure 41: List of SAEs reported by EC ...................................................................................................... 37
Figure 42: Options to modify the form ...................................................................................................... 37

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Figure 43: File number for 30th Day report by EC ............................................................................... 37

Figure 44: Successful form submission ..................................................................................................... 38
Figure 45: Sponsor Dashboard……………………………………………………………………………………...40
Figure 46: Offline CT Investigator Mapping Page …………………………………………………………...41
Figure 47: Investigator Dashboard ………………………………………………………………………………..42
Figure 48: SAE Reporting Form ………...…………………………………………………………………………..43
Figure 49: SAE Reporting Preview…………………………………………………………………………………43
Figure 50: Checklist page for 24H SAE Reporting……………………………………………………...……44
Figure 51: Checklist page for 24H SAE Reporting…………………………………………………………...44
Figure 52: Successful form submission……………………………………….………………………………….45
Figure 53: SAE Reporting List………………………………………………………….…………………………….45
Figure 54: SAE Reporting Form Preview……………………………………………….……………………….46
Figure 55: Checklist page for 14D SAE reporting……………………………………………………………46
Figure 56: Successful form submission………………………………………………………………………….47
Figure 57: Sponsor Dashboard……………………………………………………………………………………..47
Figure 58: SAE Reporting List………………………………………………………………………………………..48
Figure 59: SAE Reporting Preview…………………………………………………………………………………48
Figure 60: Checklist Page for 14D SAE Reporting by Sponsor…………………………………………49
Figure 61: Successful form submission…………………………………………………………………………..49
Figure 62: EC Dashboard……………………………………………………………………………………………....50
Figure 63: Offline CT Investigator Mapping……………………………………………………………………50
Figure 64: SAE Reporting List………………………………………………………………………………………..51
Figure 65: SAE Reporting Preview…………………………………………………………………………………51
Figure 66: Checklist Page for 30D SAE Reporting by EC………………………………………………….52
Figure 67:Successful form submission…………………………………………………………………………..52
Figure 68: Chat icon in SAE Reporting List …………………………………………..………………………..52
Figure 69: Communication Model ………………..………………………………………………………………..52
Figure 70: Previous Communication view ……………………………………………………………………..52
Figure 71: Communication Model with previous chat ……..……………………………………………..52

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